ISO 13485:2016 Transition & Auditor Refresher
The new ISO 13485:2016 standard is expected to be published in March 2016. To inform you about the changes within the new standard, we developed a training course in which these changes are explained.
With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You’ll refresh your auditing techniques and be able to identify the gaps in your current Quality Management System (QMS).
Who should attend?
Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.
You should have good knowledge of ISO 13485.
What will I learn?
You will learn about:
- Key changes and auditing techniques
- How these changes may impact your current QMS
- Revised terms, definitions and audit principles
- Impact of changes from an auditing perspective
- Developing an internal audit schedule and plan
- Relationship between ISO 9001:2015 high level structure and ISO 13485:2016
- Transition timelines and what resources may be required
How will I benefit?
This course will help you:
- Recognize the key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016 and identify how these may impact your organization
- Update your knowledge of audit principles, practices and terminology
- Refresh your skills to prepare for an ISO 13485:2016 audit
- Explore the relationship between ISO 9001:2015 High level structure and ISO13485:2016
- Make a smooth transition to ISO 13485:2016 and understand what resources may be required
- Participate in audit workshop scenarios to apply the skills you’ve learnt.
- 1 day training
- English spoken and English training material
- Including training material and lunches
* If required, you could attend the whole day of only the morning.
- € 650 whole day, € 350 only the morning
The training is also available in Dutch.
We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:
- Refresh your team’s skills and boost their confidence
- Give your team an overview of your management system(s)
- Train a group of auditors to the same level, using the same consistent techniques
For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 80 or send an email to firstname.lastname@example.org